Status:
RECRUITING
Study of AVZO-103 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Urothelial Cancer or Other Solid Tumors
Lead Sponsor:
Avenzo Therapeutics, Inc.
Conditions:
Solid Tumor Cancer
Locally Advanced
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This study, the first clinical trial of AVZO-103, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and antitumor activity of AVZO-103 when admini...
Detailed Description
Phase 1 is a dose escalation phase which will assess the safety and tolerability of AVZO-103 and determine the maximum tolerated dose (MTD) and preliminary recommended Phase 2 dose (RP2D) of AVZO-103 ...
Eligibility Criteria
Inclusion
- Key
- Patient must be an adult, 18 years of age and older with an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1 and a life expectancy of \> 3 months.
- Patients with histologically or cytologically confirmed locally advanced/metastatic malignancies for tumor types of preferred indications:
- o Locally advanced or metastatic urothelial cancer and other solid tumors (as specified in the protocol).
- Measurable disease as assessed by Investigator using RECIST v1.1.
- Agree to provide molecular test report results to confirm eligibility and archival tumor samples and/or fresh biopsy, as applicable.
- Other protocol-defined Inclusion criteria apply.
- Key
Exclusion
- Patients with active central nervous system (CNS) metastases are not eligible. Patients with asymptomatic and treated brain metastases may participate if they are radiologically stable for at least 4 weeks prior to the first dose of this study and do not require steroid treatment. Patients with suspected or confirmed leptomeningeal disease are not eligible, even if treated.
- Prior Stevens-Johnson syndrome/toxic epidermal necrolysis.
- History of drug-induced interstitial lung disease (ILD).
- History of any serious cardiovascular condition.
- Infection requiring IV antibiotics, antivirals, or antifungals within 2 weeks prior to first dose.
- History of allogenic stem cell or solid organ transplant.
- Other protocol-defined Exclusion criteria apply.
Key Trial Info
Start Date :
October 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2030
Estimated Enrollment :
355 Patients enrolled
Trial Details
Trial ID
NCT07193511
Start Date
October 2 2025
End Date
September 1 2030
Last Update
November 12 2025
Active Locations (4)
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1
Avenzo Therapeutics Recruiting Site
Orlando, Florida, United States, 32827
2
Avenzo Therapeutics Recruiting Site
Myrtle Beach, South Carolina, United States, 29572
3
Avenzo Therapeutics Recruiting Site
Nashville, Tennessee, United States, 37203
4
Avenzo Therapeutics Recruiting Site
Austin, Texas, United States, 78758